MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Tachycardia (1731); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Shock (2072)

Event Date 09/26/2019

Event Type  Death  

Manufacturer Narrative

Exemption number (b)(4).The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being conservatively filed to report that post procedure, the patient experienced tachyarrythmia, septic shock and death.It was reported that this was a mitraclip procedure performed on (b)(6) 2019 to treat a functional mitral regurgitation (mr) grade of 4.One clip was implanted reducing mr to 1.The procedure was success because improvement of cardiac output was confirmed at immediate of the procedure.There was no mitraclip deficiency during the procedure.After mitraclip procedure, the patient had fever in the night and further tachyrhythmia with hypotension.Increasing of inflammation reaction by blood draw was confirmed, and sepsis was suspected.An antibiotic was administered; however, fever was not reduced.It was noted that improved cardiac output was confirmed after the mitraclip procedure, however blood pressure was inclinable to drop at this time and not reactive to vasopressor therapy.The physician thought it was sepsis shock.Failure of several organs progressed because sepsis shock with reduced systemic vascular resistance followed a protracted course and death on (b)(6) 2019.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on this information the reported patient effects of fever, hypotension, atrial tachycardia and death appears to be related to procedural/patient conditions.A conclusive cause for the sepsis and sock cannot be determined.The reported patient effects of fever, hypotension, atrial tachycardia, sepsis, shock and death as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9215559
• MDR Text Key: 163059141
• Report Number: 2024168-2019-12783
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 90501U124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR
• Patient Weight: 81